Presentation (CTI)

OBJECTIVES: To descriptively characterize real world adverse event reporting associated with GLP 1 receptor agonists in the United States using FAERS data from 2015 to 2025, with a focus on patient demographics, reporter type, indications, clinical outcomes, and frequently reported reaction categories across individual GLP 1 agents.
METHODS: U.S. FAERS cases were extracted for albiglutide, dulaglutide, exenatide, liraglutide, lixisenatide, semaglutide, and tirzepatide. Role codes (PS/SS), demographics, reporter type, indication, clinical outcomes, and reaction MedDRA terms were summarized exactly as represented in the raw dataset and analysis using Python. Trend visualization was used to assess reporting patterns over time.
RESULTS: A total of 250,093 GLP 1 related reports were identified. Adults aged 18 to 64 years accounted for 87,735 reports and 43,421 involved patients aged 65 years or older; 222 pediatric cases were identified, while age was missing in 118,715 reports. Female patients accounted for 148,091 reports compared with 78,736 among males. Among cases with coded outcomes, hospitalization (26,462) and other serious medical events (43,005) were most common, while death was reported in 4,116 cases. Type 2 diabetes was the most frequently reported indication (77,981), followed by obesity (3,933). Across GLP 1 agents, frequently reported adverse event categories were gastrointestinal disorders, dosing or administration issues, metabolic effects, injection site reactions. Dulaglutide demonstrated high reporting across multiple categories, including gastrointestinal disorders (18,858), metabolic effects (20,117), and other events (27,865). Semaglutide injectable was commonly associated with gastrointestinal disorders (13,219), metabolic effects (9,349), dosing or administration issues (4,956), and other events (22,259). Tirzepatide exhibited the highest reporting for dosing or administration issues (33,024), injection site reactions (20,759), gastrointestinal disorders (16,702), metabolic effects (8,407), and other events (25,908).
CONCLUSIONS: GLP-1 agents show increasing real-world AE reporting in the United States, particularly for semaglutide and tirzepatide. Most reports originated from consumers, occurred among adults, and were more frequent in women.